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A single-center, open-label, randomized controlled trial to evaluate the efficacy of Sino-nasal and Mouth cAvity Rinse with an iodine-based soluTion in reducing viral load in asymptomatic CORonavirus DisEases (COVID-19)

A single-center, open-label, randomized controlled trial to evaluate the efficacy of Sino-nasal and Mouth cAvity Rinse with an iodine-based soluTion in reducing viral load in asymptomatic CORonavirus DisEases (COVID-19)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200058902
Enrollment
Unknown
Registered
2022-04-19
Start date
2022-04-16
Completion date
Unknown
Last updated
2024-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronavirus Diseases (COVID-19)

Interventions

Control group:providing basic treatment in accordance with the guidelines for the diagnosis and treatment of New Coronavirus pneumonia (trial version ninth)
Experimental group:Carrying out oral and nasal irrigation four times a day with the solution provided by the study team, and basic treatment in accordance with the guidelines for the diagnosis and tre

Sponsors

Ruijin Hospital,Shanghai Jiaotong University school of medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1.Positive result of COVID-19 infection less than 3 days by RT-PCR; 2.Age between 18-59 years; 3.Asymptomatic infection was diagnosed and medical observation was carried out at the centralized isolation treatment point; 4.can understand and provide informed consent; 5.Commit to follow the research procedures and cooperate in the implementation of the whole process research; 6.Able to communicate with the study team by phone, email or text.

Exclusion criteria

Exclusion criteria: 1.Patients with a history of nasal surgery, chronic sinusitis, or routine daily nasal flushing or nasal drug intervention; 2.Patients with thyroid diseases, respiratory diseases or other serious basic diseases; 3.Allergy to iodine; 4.Participation in another prospective COVID related research project(clinical trial) within 1 month; 5.Pregnant or breastfeeding women; 6.Pregnancy tests in serum or urine of women of childbearing age were positive; 7.Immunodeficiency patients (such as malignant tumor patients, organ or bone marrow transplant recipients, AIDS patients, and immunosuppressive drugs within 3 months); 8.Other patients considered unsuitable by the investigator to participate in this study.

Design outcomes

Primary

MeasureTime frame
Viral Negative rate by PCR on the tenth day;

Secondary

MeasureTime frame
the days that viral convert negative;Changes of viral load in pharyngeal swab;clinical discomfort reported by patients: headache, cough, runny nose, chest pain, fever, muscle soreness / fatigue, diarrhea / nausea / vomiting, loss of taste / smell and other symptoms.;

Countries

China

Contacts

Public ContactWu Beiwen

Ruijin Hospital,Shanghai Jiaotong University school of medicine

gaoan2005new@163.com+86 18917762079

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026